DepressionEarly Phase 1NCT00043602
Clinician Managed Interpersonal Psychotherapy
A Early Phase 1 study testing Standard interpersonal psychotherapy (IPT) and Clinician managed interpersonal psychotherapy (CM-IPT) in people with Depression and Depression, Postpartum, run by University of Iowa at 1 site in United States.
Trial summary
This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression, Postpartum
- What is being tested?
- Standard interpersonal psychotherapy (IPT) and Clinician managed interpersonal psychotherapy (CM-IPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Dec 2007
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between 8 and 24 weeks postpartum
- Meet DSM-IV criteria for Major Depression
- Hamilton Rating Scale for Depression score of 12 or more
Who cannot join
- Active substance abuse
- Psychotic disorders
Trial locations and contacts
1 site in 1 country.
About this study
This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.
Read the detailed description
CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.
- Conditions
- Depression, Depression, Postpartum
- Being tested
- Standard interpersonal psychotherapy (IPT), Clinician managed interpersonal psychotherapy (CM-IPT)
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard interpersonal psychotherapy (IPT)Behavioural
Participants will receive 12 sessions of IPT over 12 weeks.
Clinician managed interpersonal psychotherapy (CM-IPT)Behavioural
Participants will receive 12 sessions of CM-IPT over 1 year.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive clinician-managed interpersonal psychotherapy Receives: Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT) |
| 2 | Active comparator | Participants will receive standard interpersonal psychotherapy Receives: Behavioral: Standard interpersonal psychotherapy (IPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: Measured at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2002 (estimated)
- Study startSep 2001
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Scott P. Stuart, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043602
- Sponsor's protocol ID
- R01MH059668
- Other IDs
- R01MH059668, DSIR 83-ATAS
- Status last verified
- Sep 2013
- First submitted
- 9 Aug 2002
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician Managed Interpersonal Psychotherapy
- ClinicalTrials.gov ID
- NCT00043602
- Acronym / sponsor ID
- R01MH059668
- Conditions
- Depression, Depression, Postpartum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.
Detailed description
CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT)Participants will receive clinician-managed interpersonal psychotherapy |
| 2 | Active comparator | Behavioral: Standard interpersonal psychotherapy (IPT)Participants will receive standard interpersonal psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women between 8 and 24 weeks postpartum
- Meet DSM-IV criteria for Major Depression
- Hamilton Rating Scale for Depression score of 12 or more
Key exclusion criteria (2 listed)
- Active substance abuse
- Psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard interpersonal psychotherapy (IPT)Participants will receive 12 sessions of IPT over 12 weeks. | Behavioural | 2 |
| Clinician managed interpersonal psychotherapy (CM-IPT)Participants will receive 12 sessions of CM-IPT over 1 year. | Behavioural | 1 |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: Measured at Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott P. Stuart, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Standard interpersonal psychotherapy (IPT) and Clinician managed interpersonal psychotherapy (CM-IPT) in people with Depression and Depression, Postpartum, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (time frame: Measured at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.